eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal

This recall is currently active, issued September 25, 2024. It was issued by T.G. Eakin Limited.

Company: T.G. Eakin Limited
Recall Initiated: August 8, 2024
Posted: September 25, 2024
Recall Number: Z-3263-2024
Quantity: 35,400 cartons of 20 individually packaged seals
Firm Location: Comber Ireland
Official Source: View on FDA website ↗

Reason for Recall

On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.

Distribution

US: KY

Lot / Code Info

UDI/DI 00768455108732, Lot number 109357C553

Root Cause

Process control

Action Taken

Eakin notified its sole consignee (a distributor) of the recall via email on 08/08/2024. The notice explained the issue and requested that any affected product be discarded. The consignee notified its customers on 08/14/2024 of the recall, requesting that the affected product be discarded. For questions, please contact: In USA, Convatec Inc. on 1-800-422-8811. In Canada, Convatec Canada Limited on 1-800-465-6302.